# Commission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments, Division (4): Annex VI to Directive 2000/54/EC is replaced by the following:

Extent: E+W+S+N.I.

‘ANNEX VI
CONTAINMENT FOR INDUSTRIAL PROCESSES
(Article 4(1) and Article 16(2)(a))
Preliminary note
In the table, “Recommended” means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.
Group 1 biological agents
For work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.
Groups 2, 3 and 4 biological agents
It may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.
HEPA: High efficiency particulate air
Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).
Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.
A. Containment measures
B. Containment levels
2
3
4
General
1. Viable organisms should be handled in a system which physically separates the process from the environment
Yes
Yes
Yes
2. Exhaust gases from the closed system should be treated so as to:
Minimise release
Prevent release
Prevent release
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:
Minimise release
Prevent release
Prevent release
4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:
Inactivated by validated chemical or physical means
Inactivated by validated chemical or physical means
Inactivated by validated chemical or physical means
5. Seals should be designed so as to:
Minimise release
Prevent release
Prevent release
6. The controlled area should be designed to contain spillage of the entire contents of the closed system
No
Recommended
Yes
7. The controlled area should be sealable to permit fumigation
No
Recommended
Yes
Facilities
8. Decontamination and washing facilities should be provided for personnel
Yes
Yes
Yes
Equipment
9. Input air and extract air to the controlled area should be HEPA filtered
No
Recommended
Yes
10. The controlled area should be maintained at an air pressure negative to atmosphere
No
Recommended
Yes
11. The controlled area should be adequately ventilated to minimise air contamination
Recommended
Recommended
Yes
System of work
12. Closed systems should be located within a controlled area
Recommended
Recommended
Yes, and purpose-built
13. Biohazard signs should be posted
Recommended
Yes
Yes
14. Access should be restricted to nominated personnel only
Recommended
Yes
Yes, via an airlock
15. Personnel should shower before leaving the controlled area
No
Recommended
Yes
16. Personnel should wear protective clothing
Yes, work clothing
Yes
Yes, complete change
Waste
17. Effluent from sinks and showers should be collected and inactivated before release
No
Recommended
Yes
18. Effluent treatment before final discharge
Inactivated by validated chemical or physical means
Inactivated by validated chemical or physical means
Inactivated by validated chemical or physical means
’

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Source: https://www.legislation.gov.uk/eudr/2019/1833/annex/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-2019-1833/annex/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.